Status:
COMPLETED
A Study of Tirzepatide (LY3298176) in Chinese Participants With Type 2 Diabetes (SURPASS-CN-MONO)
Lead Sponsor:
Eli Lilly and Company
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The main purpose of this study is to investigate the efficacy and safety of Tirzepatide monotherapy in Chinese participants with Type 2 Diabetes.
Eligibility Criteria
Inclusion
- Have Type 2 Diabetes
- Have HbA1c ≥7.0% (≥53 mmol/mol) to ≤9.5% (≤80 mmol/mol) despite diet and exercise treatment
- Are of stable weight 5%) during the 90 days preceding screening and agree not to initiate a diet and/or exercise program during the study with the intent of reducing body weight other than the lifestyle and dietary measures for diabetes treatment
- Have Body Mass Index (BMI) ≥23.0 kilogram per square meter (kg/m²)
Exclusion
- Have Type 1 Diabetes
- Have a history of chronic or acute pancreatitis any time prior to study entry
- Are currently receiving treatment for diabetic retinopathy and/or macular edema
- Have a history of ketoacidosis or hyperosmolar state/coma
- Have a history of New York Heart Association Functional Classification IV congestive heart failure (CHF)
- Have acute or chronic hepatitis including a history of autoimmune hepatitis
- Use of insulin 1-year preceding screening and between screening and baseline; use of any antihyperglycemic medication 90 days preceding screening and between screening and baseline.
Key Trial Info
Start Date :
August 21 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 9 2024
Estimated Enrollment :
206 Patients enrolled
Trial Details
Trial ID
NCT05963022
Start Date
August 21 2023
End Date
October 9 2024
Last Update
October 21 2025
Active Locations (28)
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1
Chinese PLA General Hospital
Beijing, Beijing Municipality, China, 100853
2
Shunde Hospital of Southern Medical Univesity
Foshan, Guangdong, China, 528399
3
Huizhou Municipal Central Hospital
Huizhou, Guangdong, China, 516001
4
Zunyi First People's Hospital
Zunyi, Guizhou, China, 563002